Director, Process Development

JobRx, Inc.; Riverview (MI); On-site; USD 150,000 - 190,000; Full time

Job summary

Piramal Pharma Solutions, Riverview site, seeks a Director of Process Development to lead new process development activities for API synthesis, ensuring timelines and cGMP compliance. The role interfaces with QA, QC, Safety, Engineering and Operations to secure resources and deliver project milestones.

Strong leadership and experience overseeing project teams are essential. Responsibilities include evaluating projects, directing laboratory work, and preparing reports for internal and client

Qualifications

• Master or Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.
• Minimum five years in research and chemical development of drugs and fine chemicals.
• Knowledge of classic and modern synthetic methods.
• Experience building and managing research teams.

Responsibilities

• Assess new projects to identify best chemical routes and resources.
• Lead process development with resource planning and scheduling.
• Ensure timelines, specifications and cGMP requirements are met.
• Collaborate with QA, QC, Safety, Engineering, Operations and other departments.
• Develop and monitor in-process methods with Analytical Development.
• Prepare technical reports and participate in client communications.

Skills

Synthetic chemistry

Process chemistry

Project management

cGMP knowledge

Team leadership

Regulatory affairs

Stakeholder collaboration

Education

Master/PhD in Organic Chemistry

Job description

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Director, Process Development

Job Description

The Director, Process Development will serve as a member of the technical leadership for the development of new processes for the synthesis of API or API candidates at Piramal Pharma Solutions' Riverview manufacturing facility. The incumbent will help with the planning and organization of some activities in the Chemical Process Development department to ensure that timelines, specifications, cGMP requirements, and the other terms of contracts are fully respected. You will collaborate and interact with the other departments of PPS-Riverview (Quality Assurance, Quality Control, Safety, Engineering, Operations, etc.) so that all resources required for developing and approving a process are in place. Periodically this role will inform the client with the status of the project. This role may participate in potential new project assessments to provide Site Leadership with technical input regarding the feasibility of the project and may also prepare technical reports and participate in the site management meetings/team.

Key Accountabilities:

• May be asked to assess new projects with the department in order to identify the best chemical route and resources to be used in order to develop a process.
• Collaborate with Sr. Director & Regional API R&D Lead in allocating project resources (lab space, equipment and staff)
• Provide leadership to staff in regular departmental meetings, regular meetings with Managers of Process Development, and R+D project leadership roles
• Organize work within Process Development to ensure that timeliness, specifications, and FDA requirements are respected and correlate with most effective and economic use of the resources.
• Develops process research & development project plans in collaboration with the Process Development managers and other departments to ensure OTIF delivery of overall project objectives
• Ensure safe and clean lab operations
• Conduct literature searches and laboratory work to quickly identify the potential and limitations of different routes and propose the optimal solution for development.
• Contribute to the efforts to identify, characterize, and synthesize by-products and impurities generated in different steps of a process and find the conditions to diminish/suppress or remove them.
• Participate in regular departmental meetings with direct reports.
• Working with Analytical Development, direct the development of "in-process methods" to monitor chemical processes.
• Provide technical opinions and recommendations to the members of the Process Development Department in order to elaborate chemical manufacturing processes that are safe, economical, and in compliance with cGMP requirements.
• Work in the laboratory or plant (hands-on) as required.
• Generate, verify, approve, and revise BPRs, specifications, deviation reports, and development reports.
• Actively participate in technical talks to find solutions to different problems and carefully consider opinions and suggestions for future work.
• Periodically interact with Production, Analytical Development, Tech Transfer, QA, QC, Engineering, Safety, and other departments to ensure all aspects of a project under development are being taken into consideration.
• Identify and protect the original technical information as part of the company property.
• Promote a friendly and cooperative environment for all members of the department in order to facilitate open communication. Strongly encourage teamwork and carefully consider and analyze other people's opinions. Participate in meetings with potential clients and brokers to provide input to ASI's Senior Management about technical aspects of potential business opportunities for the company. Interact with clients in a positive and constructive manner.
• Work with clients for an efficient transfer and implementation of the technological /analytical information.
• Actively participate in technical talks to find solutions to different problems and carefully consider other opinions and suggestions for future work.

Education/Experience:

• Master or Ph.D. in Organic Chemistry, Medicinal Chemistry, or Chemical Engineering.
• Minimum Five (5) years' experience in research and chemical development of drugs and fine chemicals, with a proven track record of contribution in the field.
• Wide knowledge of classic and modern synthetic methods (excluding Chemical Engineers).
• Up to five (5) years of successful track record of building and managing research teams.
• Familiar with project management tools and best practices.

Skills:

• Proven skills and knowledge in project management methodology and application.

• Advanced knowledge of synthetic organic and process chemistry.
• Strong knowledge and skills with production capabilities in a pilot plant and kilo lab environments operating under current Good Manufacturing Practices (cGMP).
• Understanding of pharmaceutical drug development (Chemistry, Manufacturing and Controls; "CMC"), analytical chemistry and regulatory affairs is a strong asset.
• In depth knowledge and skills in operational leadership including resource management skills.

Job Competencies and Critical Attributes:

• EHS Focus
• Passionately Reliable
• Rapid Responsiveness
• Innovative Efficiency
• Staff Leadership
• Strategic Thinking
• Able to direct and interact with team members.
• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Self-motivated, creative, and independent.
• Ability to manage projects covering a variety of chemical compounds.

Physical demands and work environment:

The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical Demands:
  • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected.
  • Long periods of sitting and walking may also be expected in this position.
  • This position may require long periods of sitting, typing, computer entry or looking at a computer.
• Work Environment:
  • Potential limited exposure to hazardous chemicals.
  • Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.